A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treprostinil; Drug: Insulin Lispro; Drug: LY900014; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02770521

16071

I8B-JE-ITRK (Other Identifier)

Details and patient eligibility

About

The aims of this study are to evaluate:

• The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
• The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.

Enrollment: 23 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy Japanese
• Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)
• Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Exclusion criteria

• Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have participated in a clinical trial involving an investigational product within the 30 days before study entry.
• Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 4 patient groups, including a placebo group

Treprostinil (Part A)

Experimental group

Description:

Treprostinil administered as a single subcutaneous (SC) bolus injection.

Treatment:

Drug: Treprostinil

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered as a single SC bolus injection.

Treatment:

Drug: Placebo

LY900014 (Part B)

Experimental group

Description:

LY900014 (test) administered as a single SC bolus injection.

Treatment:

Drug: LY900014

Insulin Lispro (Part B)

Active Comparator group

Description:

Insulin lispro (reference) administered as a single SC bolus injection.

Treatment:

Drug: Insulin Lispro